Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

Brasilia University Hospital

Status and phase: Completed; Phase 4

Conditions: Underdosing of Unspecified General Anesthetics

Treatments: Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02454868

UBrasilia

Details and patient eligibility

About

Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies.

Full description

Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown.

Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic Cormack grade I or II.

Enrollment: 30 patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I or II
• Scheduled for surgery under general anesthesia.

Exclusion criteria

• Predicted difficult airway
• Severe neurologic or cardiologic conditions
• Recent upper airway infectious diseases

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Study arm

Experimental group

Description:

There is a single study arm. Remifentanil will be infused before intubation. The first patient will receive remifentanil 2mg/kg. If a success occurs the next patient's dose will be decreased by 0.25mg/kg and else it will be increased by 0.25mg/kg. This rule will apply recursively as Dixon's Up-And-Down Method.

Treatment:

Drug: Remifentanil